Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000560493
Ethics application status
Approved
Date submitted
22/01/2025
Date registered
2/06/2025
Date last updated
2/06/2025
Date data sharing statement initially provided
2/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
School Health Nurse Supported Child-to-Family Strategy for Diabetic Retinopathy Prevention in Bhimeshwor Municipality, Dolakha, Nepal
Scientific title
School Health Nurse Supported Child-to-Family Strategy for Diabetic Retinopathy Prevention in Bhimeshwor Municipality, Dolakha, Nepal - A Quasi-Experimental Study
Secondary ID [1] 313723 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 336323 0
Diabetic Retinopathy 336782 0
Condition category
Condition code
Metabolic and Endocrine 332863 332863 0 0
Diabetes
Eye 333810 333810 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess the effectiveness and feasibility of a school health nurse-supported child-to-family strategy to improve knowledge and preventive practices related to diabetic retinopathy (DR) among students and their families in Bhimeshwar Municipality, Dolakha, Nepal. The intervention specifically targets gaps in knowledge and preventive practices regarding DR, particularly among family members aged 30 and above.

Materials
For Students:
• Health Pamphlets: Culturally relevant content on diabetes, DR prevention, lifestyle changes, and eye check-ups.
• Pictorial Materials: Visual aids.
• Intervention Toolkit: Printed and digital resources to support learning.

For Family Members:
• Health Pamphlets: Simple, culturally appropriate content on diabetes, DR prevention, lifestyle changes, and regular eye check-ups.

Procedures:
The school that receives the intervention will be the first school that gives written consent and meets the inclusion criteria. All schools will be informed about this process before giving consent. This method fits with our study design and helps us start the intervention smoothly and fairly.
The intervention will involve school health nurses delivering educational sessions to students in Grades 7 and 8. Afterward, students will educate their family members, particularly those aged 30 and above, about DR prevention practices.

Timeline and Frequency:
The intervention will be conducted over six weeks, divided into two phases:

Pre-Intervention Assessment:
• Baseline Assessment of Parents:
Conduct baseline assessments of parents to evaluate their knowledge and practices regarding diabetes and diabetic retinopathy before the intervention.
• Educational Sessions for Intervention Students:
Hold separate educational sessions for Grades 7 and 8 students in the intervention group. Topics will cover diabetes and diabetic retinopathy prevention, healthy lifestyle habits, eye check-ups, and developing communication and leadership skills to enable students to share health messages with their family members.
• Pre-tests and Post-tests for Intervention Students:
Administer pre-tests before the educational sessions and post-tests after the sessions to assess knowledge gain in the intervention group.
• Pre-test for Control Group Students:
Conduct a pre-test for the control group students to serve as a baseline for comparison of results in the later stages of the study.

Post-Intervention Assessments:
Six weeks after the initial phase, conduct post-intervention assessments for both parents (Intervention and Control groups) and students (Intervention and Control groups) to evaluate the impact of the educational sessions and the overall intervention. Sessions
Frequency and Duration:
1. Student Education Sessions for Intervention Group:

Week 1: Introduction and Group Formation
Group Formation: Students will be divided into groups of 5-7 members, with one leader per group. An ambassador will be selected from each grade.
Pre-test: A pre-test will be conducted before the educational sessions.
Educational Sessions: Separate sessions are offered for Grades 7 and 8, covering DR prevention, communication strategies, and leadership skills, with each session lasting 3 hours for each grade.
Examples of lifestyle changes emphasized to address and prevent diabetic retinopathy (DR):
1. Maintaining Healthy Blood Sugar Levels
Example: Consistently monitoring and managing blood glucose levels through diet, exercise, and medication can prevent or slow the progression of diabetic retinopathy.
2. Healthy Diet
Example: Eating a balanced diet rich in fruits, vegetables, whole grains, lean proteins, and healthy fats helps in maintaining optimal blood sugar levels and supporting overall eye health.
3. Regular Physical Activity
Example: Engaging in regular exercise (such as walking, swimming, or cycling) helps regulate blood sugar levels, reduce body weight, and improve circulation, which can protect against the development of retinopathy.
4. Blood Pressure Control
Example: Keeping blood pressure within a healthy range through a combination of diet, exercise, and medication reduces the risk of developing diabetic retinopathy, as high blood pressure can worsen eye damage.
5. Managing Cholesterol Levels
Example: Monitoring and controlling cholesterol levels through diet, exercise, and medication helps protect the blood vessels in the eyes, which are at risk due to diabetes-related vascular damage.
6. Regular Eye Exams
Example: Scheduling regular eye exams with an ophthalmologist to detect early signs of diabetic retinopathy. Early detection can lead to timely treatment and prevent vision loss.
7. Smoking Cessation
Example: Quitting smoking helps improve circulation and overall health, reducing the risk of complications like diabetic retinopathy and other cardiovascular diseases.
8. Stress Management
Example: Practicing stress management techniques such as meditation, yoga, or mindfulness helps in managing blood sugar levels and reduces the risk of developing complications related to diabetes.

Post-test: A post-test will be administered after the session.

Pamphlets and Logbook: Students will receive pamphlets and a daily tracking logbook to monitor their engagement. These logbooks will be reviewed weekly by the school health nurse, who will also collect and verify that the weekly educational activities were completed by students with their family members.

Support and Troubleshooting: If any challenges arise while providing education to family members, they will be discussed within the team or with the school health nurse.

Week 2: Reinforcement of Key Concepts
The school health nurse will conduct follow-up educational sessions for both grades to reinforce the concepts covered in Week 1, with each session lasting 2 hours for each grade.

Week 3: Group Presentations and Peer Learning
Each group will present their learnings for 15 minutes, followed by a question-and-answer session to promote peer learning. The total session will last 3 hours for each grade.

Week 4: Debate Competition
A debate on diabetic retinopathy (DR) prevention will be held for 10 minutes per group between groups from each grade. Prizes will be awarded to the top three groups from each grade, with health teachers serving as judges. The total session time will be 2 hours.

Week 5: Role-Play Activities
Students will perform a 10-minute role-play on DR prevention, conducted separately for each grade to demonstrate their understanding interactively. The session will last for 2 hours.

Week 6: Student-Led Educational Sessions and Final Assessments
Voluntarily, students will lead educational sessions for their classmates for 10 minutes to reinforce key concepts. The session will last for 2 hours.
Post-intervention assessments will be conducted 42 days after the first educational session in both the intervention and control groups to evaluate knowledge retention among students and changes in knowledge.

2. Family Education Sessions:
Daily Family Sessions:
Students will conduct daily educational sessions with their family members aged 30 and above (5-20 minutes).

Logbook Recording: Students will record the daily activities in a logbook. If a session is not conducted, students will document the reason for not providing the educational message. This helps track consistency and provides insight into any barriers faced.

Content Delivery Method:
Face-to-face sessions will be delivered by the students to their family members using printed health pamphlets as support materials.

Key Personnel:
School Health Nurse: A trained healthcare professional responsible for delivering educational sessions to students and supervising the intervention.
Students: Grades 7 and 8 will be trained by the school health nurse to communicate DR prevention effectively to their families.
Research Team: Monitors the intervention and collects data under the guidance of the principal investigator.

Location:
Intervention Settings: The intervention will take place in selected schools in Bhimeshwar Municipality, Dolakha.
Family Settings: Family-based education will occur in students' homes by students.

Intervention Modifications:
Engagement Challenges: If challenges arise in participant engagement, materials may be modified with additional visual aids or more relatable examples, based on feedback from students and families.

Adherence and Fidelity:
Supervision: Close monitoring of educational sessions by the school health nurse and research team.
Student Monitoring: Students will report on their interactions with family members and any difficulties encountered.
Strategies for Maintaining Fidelity:
Ongoing support for the school health nurse.
Regular feedback loops to assess the intervention’s effectiveness.
Refresher sessions if necessary to maintain fidelity.

Allocation to Intervention/Control Group:
Study Design: The intervention will be implemented in one school, and two schools will serve as control schools. These schools have been purposively selected based on the availability of a school health nurse and the number of students.
Control Group: The control schools will continue with their standard practices without the intervention, allowing for comparison with the intervention school.
Allocation Process: The intervention school will be assessed first, with assessments conducted before and after the intervention. The control schools will receive the intervention after the first set of schools have completed the intervention phase.
Planned vs. Actual Adherence:
Planned Adherence: Ensuring students and families receive and understand the educational material within the established timeline.
Actual Adherence: Monitored through session attendance, intervention completion, and feedback from students and families.
Intervention code [1] 330319 0
Prevention
Comparator / control treatment
The study will include one intervention school and two control schools. Two schools were selected for the control group because each has fewer students, and combining them allows for a 1:1 ratio of participants between the intervention and control groups.

Students in the control group will not receive diabetic retinopathy prevention sessions. Instead, they will attend general health education sessions on unrelated topics, delivered by the school nurse. These sessions are designed to keep students engaged without influencing outcomes related to diabetic retinopathy.

Both groups will undergo baseline and post-intervention assessments at the same time points to evaluate differences in knowledge and preventive practices. This design will help assess the effectiveness of the School Health Nurse-Supported Child-to-Family Strategy for Diabetic Retinopathy Prevention.
Control group
Active

Outcomes
Primary outcome [1] 340452 0
Knowledge change on Diabetes and Diabetic Retinopathy among students
Timepoint [1] 340452 0
Baseline and 6 weeks following end of education sessions.
Secondary outcome [1] 444114 0
Knowledge change on Diabetic Retinopathy among family members age 30 and above
Timepoint [1] 444114 0
Baseline and 6 weeks following end of baseline
Secondary outcome [2] 444115 0
Preventive practice change in family members age 30 and above
Timepoint [2] 444115 0
Baseline and 6 weeks following end of baseline
Secondary outcome [3] 444116 0
Student retention in health promotion activities will be assessed to measure ongoing engagement and participation throughout the intervention, helping evaluate its effectiveness in maintaining involvement.
Timepoint [3] 444116 0
Following the initial educational session, post-intervention assessments will be conducted at the end of 6 weeks. Data will be collected at specific timepoints: Baseline: Prior to the intervention, baseline assessments will be conducted for both students (intervention and control) and their family members (intervention and control). Post-Intervention: After 6 weeks, post-intervention assessments will be conducted to evaluate changes in knowledge among students in both the intervention and control groups, as well as changes in knowledge and preventive practices among their family members (intervention and control). Follow-Up: In the intervention group, retention data will be collected weekly using a logbook throughout the 6-week intervention period to track students' involvement in health promotion activities.
Secondary outcome [4] 447429 0
Perception, behavior changes, and motivation among family members and students.
Timepoint [4] 447429 0
At the end of the study.
Secondary outcome [5] 448289 0
Motivation among School Health Nurses
Timepoint [5] 448289 0
At the end of study

Eligibility
Key inclusion criteria
Inclusion criteria
For students:
- Aged 10 years and above
- Enrollment in grades 7 or 8 in the selected school
- Parents’ consent to participate
- Student's assent to participate in the study
- Living with family members of age 30 and above.
For family members:
- Aged 30 years and above
- Reside in the same household as the selected student, sharing the same kitchen
- Available for participation in the intervention and follow-up assessments during the study period
Minimum age
10 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For students:
• Students who are differently abled (blind, deaf, or non-verbal.)
• Students whose family members do not live with them.
For family members:
• Family members were diagnosed with diabetic retinopathy.
• Family members are unable to participate in both the baseline and end-line surveys.
• Family members who are differently abled (blind, deaf, or non-verbal.)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Quasi experimental (Intervention and control group purposively selected)

The selection process for this study will be carried out as follows: Schools will be purposively selected based on specific inclusion criteria, including the presence of a school health nurse. Within each selected school, students will be chosen using simple random sampling, with the number of students selected from grades 7 and 8 being proportional to the total number of students in these grades. Additionally, the parents of the selected students, aged 30 and above, who are available during the data collection period, will be interviewed.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/01/2025
Date of last participant enrolment
Anticipated
Actual
5/02/2025
Date of last data collection
Anticipated
Actual
6/05/2025
Sample size
Target
70
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 26837 0
Nepal
State/province [1] 26837 0
Bagmati

Funding & Sponsors
Funding source category [1] 318189 0
University
Name [1] 318189 0
School of Health and Allied Sciences, Pokhara University
Country [1] 318189 0
Nepal
Primary sponsor type
Individual
Name
Ramesh Shrestha, School of Health and Allied Sciences, Pokhara University
Address
Country
Nepal
Secondary sponsor category [1] 320575 0
None
Name [1] 320575 0
Address [1] 320575 0
Country [1] 320575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316841 0
Pokhara University Institutional Review Committee
Ethics committee address [1] 316841 0
Ethics committee country [1] 316841 0
Nepal
Date submitted for ethics approval [1] 316841 0
29/12/2024
Approval date [1] 316841 0
05/01/2025
Ethics approval number [1] 316841 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139170 0
Mr Ramesh Shrestha
Address 139170 0
School of Health and Allied Sciences, Pokhara University, Pokhara Metropolitan City-30 Kaski, Nepal
Country 139170 0
Nepal
Phone 139170 0
+977 9843697989
Fax 139170 0
Email 139170 0
[email protected]
Contact person for public queries
Name 139171 0
Ramesh Shrestha
Address 139171 0
School of Health and Allied Sciences, Pokhara University, Pokhara Metropolitan City-30 Kaski, Nepal
Country 139171 0
Nepal
Phone 139171 0
+977 9843697989
Fax 139171 0
Email 139171 0
[email protected]
Contact person for scientific queries
Name 139172 0
Ramesh Shrestha
Address 139172 0
School of Health and Allied Sciences, Pokhara University, Pokhara Metropolitan City-30 Kaski, Nepal
Country 139172 0
Nepal
Phone 139172 0
+977 9843697989
Fax 139172 0
Email 139172 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers

• Individual researcher and organization.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified participant data, excluding any information that could reveal individual identities, will be shared upon request. Data will be made available for research purposes with appropriate citation and approval from the Principal Investigator (PI). The shared data will include [specify: all collected data, data related to published results, or primary outcome data only, as applicable].

What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• For primary and secondary analysis

When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• On request to PI and corresponding author. email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.